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NIH StrokeNet Clinical Trials and Biomarker Studies for Stroke Treatment, Recovery, and Prevention (U01 - Clinical Trial Optional)

PAR
Tuesday, January 9, 2018
Friday, November 6, 2020
U01
PAR-18-561

Funding Opportunity Purpose

This FOA encourages applications for multi-site exploratory and confirmatory clinical trials focused on promising interventions, as well as biomarker-or outcome measure validation studies that are immediately preparatory to trials in stroke prevention, treatment, and recovery. Successful applicants will collaborate and conduct the trial within the NIH StrokeNet. Following peer review, NINDS will prioritize trials among the highest scoring to be conducted in the NIH StrokeNet infrastructure. The NIH StrokeNet National Coordinating Center (NCC) will work with the successful applicant to implement the proposed study efficiently and the National Data Management Center (NDMC) will provide statistical and data management support. The NIH StrokeNet Regional Coordinating Centers (RCCs) and their affiliated clinical sites will provide recruitment/retention support as well as on-site implementation of the clinical protocol. The NIH StrokeNet network will also be uniquely poised to collaborate with other US and international consortia necessary to conduct larger, definitive trials of promising interventions for stroke treatment, prevention, and recovery. NINDS intends that all multi-center clinical trials in stroke treatment, recovery, or prevention supported by NINDS will be conducted in the NIH StrokeNet and that only in exceptional circumstances will NINDS consider funding multi-site stroke clinical trials outside of this program. Applicants do not need to be part of the existing NIH StrokeNet infrastructure to apply under this FOA.

NIH StrokeNet Small Business Innovation Clinical Trials and Biomarker Studies for Stroke Treatment, Recovery, and Prevention (U44 - Clinical Trials Optional)

PAR
Tuesday, January 9, 2018
Clinical Trials Research
Wednesday, January 6, 2021
U44
PAR-18-563

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) encourages Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) that propose exploratory and confirmatory clinical trials focused on promising interventions, as well as biomarker-or outcome measure validation studies that are immediately preparatory to trials in stroke prevention, treatment, and recovery. The program will utilize the cooperative agreement mechanism to enable milestone-drive projects. Successful applicants will collaborate and conduct the trial within the NIH StrokeNet. Following peer review, NINDS will prioritize trials among the highest scoring to be conducted in the NIH StrokeNet infrastructure. The NIH StrokeNet National Coordinating Center (NCC) will work with the successful applicant to implement the proposed study efficiently and the National Data Management Center (NDMC) will provide statistical and data management support. The NIH StrokeNet Regional Coordinating Centers (RCCs) and their affiliated clinical sites will provide recruitment/retention support as well as on-site implementation of the clinical protocol. The NIH StrokeNet network will also be uniquely poised to collaborate with other US and international consortia necessary to conduct larger, definitive trials of promising interventions for stroke treatment, prevention, and recovery.

Analytical Validation of Candidate Biomarkers for Neurological Disease (U01 Clinical Trial Optional)

PAR
Friday, December 22, 2017
Tuesday, September 8, 2020
U01
PAR-18-550

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to support rigorous analytical validation of candidate biomarker measures or endpoints in a manner that is consistent with FDA guidelines. Analytical validation establishes that the performance characteristics of the biomarker measurement or endpoint are acceptable for its intended use.

Analytical Validation of a Candidate Biomarker for Neurological Disease (U44 - Clinical Trial Optional)

PAR
Friday, December 22, 2017
Translational Research, Clinical Trials Research
Tuesday, September 8, 2020
U44
PAR-18-549

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to support applications from Small Business Concerns (SBCs) to perform rigorous analytical validation of candidate biomarker measures or endpoints in a manner that is consistent with FDA guidelines. Analytical validation establishes that the performance characteristics of the biomarker measurement or endpoint are acceptable for its intended use.

Clinical Validation of a Candidate Biomarker for Neurological Disease (U44 - Clinical Trial Optional)

PAR
Friday, December 22, 2017
Translational Research, Clinical Trials Research
Tuesday, September 8, 2020
U44
PAR-18-548

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is encourage applications from Small Business Concerns (SBCs) to support rigorous clinical validation of a candidate biomarker using retrospective and/or prospective methods in a manner that is consistent with the purpose of the biomarker. This FOA assumes that: 1) a candidate biomarker has already been identified, 2) an analytical method has been developed and validated that is consistent with the purpose of the biomarker and 3) a working hypothesis regarding context of use is in place. The goal of this FOA is to facilitate the advancement of robust and reliable biomarkers of neurological disease for use in multi-site clinical trials and clinical practice.

Limited Competition: Clinical Research Sites for MACS/WIHS Combined Cohort Study, MACS/WIHS-CCS (U01-Clinical Trials Not Allowed)

RFA
Friday, December 22, 2017
Thursday, May 3, 2018
U01
RFA-HL-19-008

Funding Opportunity Purpose

The purpose of this limited competition Funding Opportunity Announcement (FOA) is to advance knowledge of the HIV infection, with a focus on HIV-related comorbidities by supporting current Clinical Research Sites (CRS) of the Multi-Center AIDS Cohort Study (MACS) and the Womens Interagency HIV Study (WIHS) Combined Cohort Study (MACS/WIHS-CCS). Through this FOA each CRS will implement the full MACS/WIHS-CCS unified science agenda and provide expertise to lead part of the unified science agenda (e.g., protocol development, as a reading center, or laboratory). Targeted recruitment will be supported with justification. A companion cooperative agreement will support the MACS/WIHS-CCS Data Analysis and Coordination Center (DACC).

Limited Competition: Data Analysis and Coordination Center for the MACS/WIHS Combined Cohort Study, MACS/WIHS-CCS (U01 Clinical Trials Not Allowed)

RFA
Friday, December 22, 2017
Thursday, May 3, 2018
U01
RFA-HL-19-007

Funding Opportunity Purpose

The purpose of this limited competition Funding Opportunity Announcement (FOA) is to support a Data Analysis and Coordination Center (DACC) for the Multicenter AIDS Cohort Study (MACS) and the Womens Interagency HIV Study (WIHS) Combined Cohort Study (MACS/WIHS-CCS). The DACC will work as a member of the MACS/WIHS-CCS consortium to advance knowledge of basic and clinical science, and the epidemiology of HIV infection in the US, with a focus on HIV-related comorbidities. A companion cooperative agreement will support MACS/WIHS-CCS Clinical Research Sites (CRS)

Blueprint Neurotherapeutics Network (BPN): Small Molecule Drug Discovery and Development for Disorders of the Nervous System (U44) - Clinical Trial Optional

PAR
Thursday, December 21, 2017
Translational Research, Clinical Trials Research
Friday, May 8, 2020
U44
PAR-18-541

Funding Opportunity Purpose

The Blueprint Neurotherapeutics Network (BPN) encourages applications from small businesses seeking support to advance their small molecule drug discovery and development projects into the clinic. Participants in the BPN are responsible for conducting all studies that involve disease- or target-specific assays, models, and other research tools and receive funding for all activities to be conducted in their own laboratories. In addition, applicants will collaborate with NIH-funded consultants and can augment their project with NIH contract research organizations (CROs) that specialize in medicinal chemistry, pharmacokinetics, toxicology, formulations development, chemical synthesis including under Good Manufacturing Practices (GMP), and Phase I clinical testing. Projects can enter either at the Discovery stage, to optimize promising hit compounds through medicinal chemistry, or at the Development stage, to advance a development candidate through Investigational New Drug (IND)-enabling toxicology studies and phase I clinical testing. Projects that enter at the Discovery stage and meet their milestones may continue on through Development. BPN awardee institutions retain their assignment of IP rights and gain assignment of IP rights from the BPN contractors (and thereby control the patent prosecution and licensing negotiations) for drug candidates developed in this program.

Blueprint Neurotherapeutics Network (BPN): Small Molecule Drug Discovery and Development of Disorders of the Nervous System (UG3/UH3) - Clinical Trial Optional

PAR
Thursday, December 21, 2017
Friday, May 8, 2020
UG3/UH3
PAR-18-546

Funding Opportunity Purpose

The Blueprint Neurotherapeutics Network (BPN) invites applications from neuroscience investigators seeking support to advance their small molecule drug discovery and development projects into the clinic. Participants in the BPN are responsible for conducting all studies that involve disease- or target-specific assays, models, and other research tools and receive funding for all activities to be conducted in their own laboratories. In addition, applicants will collaborate with NIH-funded consultants and can augment their project with NIH contract research organizations (CROs) that specialize in medicinal chemistry, pharmacokinetics, toxicology, formulations development, chemical synthesis including under Good Manufacturing Practices (GMP), and Phase I clinical testing. Projects can enter either at the Discovery stage, to optimize promising hit compounds through medicinal chemistry, or at the Development stage, to advance a development candidate through Investigational New Drug (IND)-enabling toxicology studies and phase I clinical testing. Projects that enter at the Discovery stage and meet their milestones may continue on through Development. BPN awardee Institutions retain their assignment of IP rights and gain assignment of IP rights from the BPN contractors (and thereby control the patent prosecution and licensing negotiations) for drug candidates developed in this program.

BRAIN Initiative: Clinical Studies to Advance Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (UH3 - Clinical Trial Required)

RFA
Thursday, December 21, 2017
Thursday, October 22, 2020
UH3
RFA-NS-18-023

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to encourage investigators to pursue a small clinical trial to obtain critical information necessary to advance recording and/or stimulating devices to treat central nervous system disorders and better understand the human brain (e.g., Early Feasibility Study). Clinical studies supported may consist of acute or short-term procedures that are deemed Non-Significant Risk (NSR) by an Institutional Review Board (IRB), or Significant Risk (SR) studies that require an Investigational Device Exemption (IDE) from the FDA, such as chronic implants. The clinical trial should provide data to answer key questions about the function or final design of a device. This final device design may require most, if not all, of the non-clinical testing on the path to more advanced clinical trials and market approval. The clinical trial is expected to provide information that cannot be practically obtained through additional non-clinical assessments (e.g., bench top or animal studies) due to the novelty of the device or its intended use. Activities supported by this Funding Opportunity include a small clinical trial to answer key questions about the function or final design of a device. As part of the BRAIN Initiative, NIH has initiated a Public-Private Partnership Program (BRAIN PPP) that includes agreements (Memoranda of Understanding, MOU) with a number of device manufacturers willing to make such devices available, including devices and capabilities not yet market approved but appropriate for clinical research. In general it is expected that the devices' existing safety and utility data will be sufficient to enable new IRB NSR or FDA IDE approval without need for significant additional non-clinical data. For more information on the BRAIN PPP, see http://braininitiative.nih.gov/BRAIN_PPP/.

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